Action Points

Note that this randomized trial comparing stenting with endarterectomy for carotid stenosis found that both strategies carry a similar low risk of major stroke.

Be aware that medical management of carotid atherosclerosis has improved significantly since this trial was conducted.

LOS ANGELES -- The latest finding on carotid stenting versus endarterectomy for asymptomatic patients confirmed that stenting is "no worse than surgery," but -- and there is a big "but" here -- that finding comes from a comparison that may no longer reflect real world conditions.

At 5 years, the overall event rate was 3.8% for stenting vs 3.4% for surgery, a difference of 0.4%, which met the test for noninferiority (P=0.01). There was, as has been observed in other trials of carotid stenting, a trend toward a higher event rate during the first 30 days in the stent group (2.9% vs 1.7%, P=0.33) but that was driven by a numerically higher rate of minor strokes within the first 30 days in the stent group.

The take-home, said Lawrence Wechsler, MD, of the University of Pittsburgh Medical Center, is that "stenting is a reasonable alternative to endarterectomy.

"There was no difference in the rate of major strokes," he said. "I don't really make much of that difference in minor strokes. We never want a patient to have a stroke, but the important finding is that there was no difference in major strokes or in ipsilateral stroke."

The trial enrolled 1,453 asymptomatic patients who had carotid narrowing of at least 70% and randomized 1,089 to stenting with embolic protection. The average age of patients was 68, and most of them were white. Roughly 60% were men.

Even as he was reporting the findings at a press conference here, Wechsler cautioned that the trial enrolled patients during what was a different era in treatment of asymptomatic carotid stenosis, predating current recommendations for medical managements, which "make a big difference," he told MedPage Today.

That changing era also presented a problem for trial itself, which began enrollment in 2005, but by 2010 began to run into significant difficulties in enrollment. As a result the trial was halted in 2013, short of the intended enrollment goal. And consequently the findings were powered at 75%, not the 80% as originally designed.

Asked to elaborate on the enrollment difficulties, Wechsler said it was a confluence of events including the 2010 publication of results of a similarly designed trial (CREST), the FDA approval of the Acculink carotid stent that gave patients the option of stenting without enrolling in a trial, and major changes in recommended medical management.

Stroke neurologist Ralph Sacco, MD, MS, a former American Heart Association president, and chairman of neurology at the University of Miami's Miller School of Medicine, told MedPage Today that there had been a sea change in recommendations for medical management including "lower LDL targets, lower glucose, lower blood pressure, aggressive use of statins, diet and exercise."

Wechsler agreed, noting that "we always talked about those things, but now we are really aggressively addressing lifestyle -- exercise and diet."

That change in medical management is why "we really need to encourage enrollment in CREST 2, which will compare endarterectomy with modern medical management in one arm and stenting to modern medical management in the other arm."

Asked if the ACT 1 results provide information that would be useful in helping patients decide between surgery and stenting, both Wechsler and Sacco said the results were reassuring but the decision to choose stenting over surgery has to be a patient-by-patient one.

Wechsler said he talks to patients about the need for general anesthesia with surgery as well as the scar created by surgery, and also discusses the long-term efficacy data for surgery. He does not, he said, discuss the observed increase in minor strokes with stenting.

"It may be that one center has a really top notch neurosurgeon, but doesn't have the same expertise in stenting," Wechsler said.

As noted, the ACT 1 study was limited by the long enrollment period -- 8 years -- as well as by a lack of information about the patients who decided not to enroll in the trial.

The study was funded by Abbott Vascular. Wechsler reports grant support from Abbott Vascular during the conduct of the study, and other support from Silk Road Medical outside the submitted work.

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